PHARMAFull-time
Document Lifecycle Management
By Admin · Quality Assurance & Quality Control
HYDERABAD (IN)ONSITEPOSTED: 9/10/2026
PHARMAFull-time
HIRING ORGANIZATIONLONZALife Sciences / Pharmaceutical Manufacturing / Healthcare Technology
ROLE OVERVIEW
Own compliant GMP documentation lifecycle and QA oversight activities in Hyderabad, with responsibility for document archiving, true copy scanning, retention decisions and retain-sample disposition.
ROLE DEFINITION & RESPONSIBILITIES
- •Ensure compliant management of quality-relevant documents from finalization through customer dispatch or destruction
- •Provide QA oversight for documentation integrity, traceability and GMP archiving compliance
- •Drive disposition decisions for archived paper documents in collaboration with QA Operations and document owners
- •Own and maintain the True Copy Scanning process and associated SOPs
- •Provide training for employees involved in scanning and documentation workflows
- •Maintain documentation-system access rights and segregation of duties
- •Coordinate with external archiving service providers to ensure compliance with Lonza standards
- •Evaluate expired GMP documents and retain samples and determine compliant destruction or customer-dispatch actions
Reporting Hierarchy: Reports within Lonza’s Quality Systems & Compliance organization and collaborates closely with QA Operations, document owners and external archiving partners
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Experience in Quality Assurance or Documentation Management within a regulated GxP/GMP environment
- Strong understanding of data integrity principles
- Knowledge of GMP documentation and archiving requirements
- Understanding of Annex 11 and 21 CFR Part 11
- Strong decision-making, risk evaluation and coordination skills
- Fluent written and spoken English
PREFERRED QUALIFICATIONS
- •German language skills
- •Experience with electronic documentation or quality-management systems
- •Experience managing external archiving providers
- •Experience with True Copy or controlled document scanning processes
REQUIRED VERIFIED SKILLS
GMP
GxP
Quality Assurance
Documentation Management
Data Integrity
GMP Archiving
Annex 11
21 CFR Part 11
True Copy Scanning
SOP Management
Retention Management
Risk Assessment
Quality Records
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional benefits and performance-based compensation programs; globally connected quality network; career development opportunities
No compensation figures are disclosed in the supplied posting. Compensation should therefore be evaluated directly through Lonza’s recruitment process rather than inferred from the role title.
ORGANIZATION CONTEXT & CULTURE
Lonza is a global life-sciences company supporting customers in developing and manufacturing medicines, with a globally connected network of sites across multiple continents.
TEAM SIZE: 30+ sites globally
INDUSTRY: Life Sciences / Pharmaceutical Manufacturing / Healthcare Technology
Culture: Lonza emphasizes collaboration, accountability, excellence, passion and integrity, with a focus on enabling customers to turn breakthrough ideas into viable therapies.
EXPECTED CAREER ROADMAP
Strong opportunity to deepen expertise in GMP quality systems, documentation governance, data integrity and compliance, with potential progression into senior QA, quality systems, documentation governance or compliance leadership roles.
APPLICATION ADVISORY
Highlight hands-on GMP/QA documentation experience; demonstrate knowledge of Annex 11 and 21 CFR Part 11; emphasize data-integrity and document-lifecycle expertise; provide examples of audit-ready documentation, retention decisions and SOP ownership; showcase cross-functional coordination and risk-based decision-making.
RECOMMENDED TRAINING
1/5
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